These recent but separate actions mean that Mitsubishi Tanabe Pharma’s intravenous infusion therapy is now listed on each province’s individual public formularies, and covered by their public health plans. As such, the therapy is available by prescription to patients at a controlled and pre-determined cost.
“This new coverage is an important step forward for eligible patients living with ALS,’’ said Lorne Zinman, MD, director of the ALS and Neuromuscular Clinic at the Sunnybrook Health Sciences Centre in Toronto, Ontario, in a press release.
“It provides the opportunity for patients with public drug benefits and their treating physicians to, when clinically appropriate, utilize this innovative therapy to help slow the loss of function in patients with ALS,’’ Zinman added.
The formularies, which administer public health and prescription medicine insurance plans, include the Ontario Drug Benefit Formulary (Exceptional Access Program), the New Brunswick Drug Plan (special authorization), and the Alberta Drug Benefit List (special authorization).
Mitsubishi Tanabe is continuing discussions with other provinces, territories, and federal agencies about listing the treatment under their publicly funded programs.
“The listing of Radicava on the Ontario public formulary is an important step in our long-term commitment to the ALS community in Canada,” said Atsushi Fujimoto, president of Mitsubishi Tanabe Pharma Canada. “We want to thank the government of Ontario for its leadership in making this treatment accessible to ALS patients … eligible for coverage under the Ontario Drug Benefit program.”
Fujimoto made similar statements about Radicava’s addition to the public health plans of New Brunswick and Alberta. It’s estimated that between 2,500 and 3,000 Canada residents live with ALS, a progressive neuromuscular disorder that destroys nerve cells and causes disability.
“The availability of Radicava on the Ontario Drug Benefit Formulary (Exceptional Access Program) is an important milestone and demonstrates that together the collective voices of the ALS community can make a difference,” said Tammy Moore, CEO, ALS Society of Canada. “We are pleased the Government of Ontario has moved quickly in a complex process of approval and negotiation.”
In the United States, where about 5,000 individuals are diagnosed with ALS annually, the treatment was approved in 2017 and is marketed by MT Pharma America. Radicava was developed by Mitsubishi Tanabe Pharma.
The therapy has a neuroprotective effect, and slows the diminishment of physical functioning in ALS patients by removing free radicals in the nervous system. Free radicals are byproducts of normal cellular processes that produce energy. Normally, they are swiftly removed by the body. If they remain they can cause oxidative stress, leading to damage and cell death. Such stress is thought to be one of the causes of nerve cell death in ALS.
Radicava is administered intravenously — into the bloodstream — in 28-day cycles. The therapy begins with a patient being given the therapy for 14 consecutive days, followed by a two-week treatment-free period. Patients then receive an infusion during 10 of the next 14 days, followed by another two-week treatment-free period.
Patients are prescribed 60 mg of Radicava per treatment, and each treatment takes about an hour to administer.
The U.S. Food and Drug Administration’s approval of Radicava was based on the results of Study 19, a placebo-controlled Phase 3 clinical trial (NCT01492686), which evaluated Radicava’s effectiveness and safety in treating ALS.
A recent post hoc analysis of Study 19 suggests the treatment is effective in slowing ALS progression across a year’s use.
The therapy was approved to treat ALS in Japan and South Korea in 2015. It was granted marketing authorization in Canada in 2018, and in Switzerland last year.
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